Regulatory Affairs Manager (m/f/d) in Active Medical Device Software (m/f/d) - Freiburg
In this position you will be mainly responsible for managing regulatory aspects of medical devices, focusing on software. Furthermore, you will coordinate and manage and approvals by local regulatory experts and work as part of projects teams to create launch materials for new products and indications.
What are your tasks as "SR Regulatory Affairs Manager (m/f/x)"?
- You will advise and complete Technical Documentations, with focus on software as a medical device
- You will implement regulatory requirements according to MDR, MDD, IVD
- You will develop customised solutions to fulfil client needs combined with regulatory requirements
- You will manage customer relationship management and engagement management
What requirements do you need for "SR Regulatory Affairs Manager (m/f/x)"?
- Bachelor's degree in computer science or comparable qualifications in the field of software
- At least 2 years as Regulatory Affairs Manager
- Strong knowledge of EU and ROW regulations and guidance pertaining to medical device
- knowledge of the software lifecycle process, ideally according to IEC 62304 and risk management
- Excellent language skills in German and English (written and spoken)
- Excellent organisational, prioritisation and planning skills
What does the position offer to you?
- Exciting projects & personal development
- Flexible work hours
- Home office
- Pension plan and childcare
- 30 vacation days & 6 additional compensation days
About the client?
Our client a market leader across pharmaceuticals, medical devices and invitro diagnostics. Based on over 30 years of experience, they are a global leader in health care product that empower people to achieve their individual goals.
Are you interested in such company? Then you should apply now! If you would like to receive Information, I would be happy to let you more about it and other opportunities:
Contact for application:
- E-Mail: email@example.com
- Tel: +49 (0)89 / 26200311